Received: 18 June 2023

| Accepted: 18 July 2023

DOI: 10.1002/rmb2.12530

ORIGINAL ARTICLE

Therapeutic efficacy and safety of a free-­standing motorizedejaculation aid for patients with intravaginal ejaculatory
dysfunction
Shinichiro Fukuhara1 | Masato Shirai2 | Norichika Ueda1 | Kentaro Takezawa1 |Keisuke Ishikawa2 | Ippei Hiramatsu3 | Yuka Uesaka2 | Taiji Nozaki2 | Atsushi Iwasa4 |Kazuhiro Kobayashi5 | Norio Nonomura1 | Akira Tsujimura2
1
Department of Urology, Osaka University
Graduate School of Medicine, Suita, Japan2

Department of Urology, Juntendo
University Urayasu Hospital, Urayasu,
Japan
3
Department of Urology, Juntendo
University Graduate School of Medicine,Tokyo, Japan
4

Iwasa Clinic, Osaka, Japan5

D Clinic Tokyo, Tokyo, Japan

Correspondence
Akira Tsujimura, Department of Urology,
Juntendo University Urayasu Hospital, 2-­
1-­1 Tomioka, Urayasu 279-­0 021, Japan.
Email: atsujimu@juntendo.ac.jp

Abstract
Purpose: There are no approved drugs or devices for the treatment of intravaginal
ejaculation disorders, and treatment is often difficult. This study aimed to evaluate
the efficacy and safety of the A10 Cyclone SA + PLUS® ejaculation aid (Rends Co.,
Ltd., Chiba, Japan), which allows the user to adjust the intensity of stimulation, forintravaginal ejaculation disorders.
Methods: Each participant was instructed to perform practice masturbation with the
A10 Cyclone SA + PLUS to simulate vaginal ejaculation. After 8 weeks of training, theparticipants were asked about their intravaginal ejaculation status. Sexual function
was also evaluated before and after the training using several specific questionnaires,
including the numerical rating scale for ejaculatory satisfaction.
Results: Among the 10 participants (41.5 ± 3.21 years) who completed the training
and questionnaire evaluation, four (40%) became capable of intravaginal ejaculation.
The questionnaire evaluation showed predominant improvement after training in the
ejaculation-­capable group according to the numerical rating scale, which expresses
satisfaction with ejaculation. The participants experienced no significant adverse
events.
Conclusion: As no effective treatment currently exists for intravaginal ejaculation disorders, we conclude that the A10 Cyclone SA + PLUS may be one treatment tool for
intravaginal ejaculation disorders with good efficacy and no adverse events.
KEYWORDS

ejaculatory disorders, erectile dysfunction, intravaginal ejaculatory dysfunction, masturbationaid, sexual function

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution inany medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2023 The Authors. Reproductive Medicine and Biology published by John Wiley & Sons Australia, Ltd on behalf of Japan Society for Reproductive Medicine.
Reprod Med Biol. 2023;22:e12530.
https://doi.org/10.1002/rmb2.12530

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FUKUHARA et al.

I NTRO D U C TI O Nintercourse. In addition, intravaginal EjD is often the result of inadequate masturbation practices, which may include nonmanual

While the world's population is increasing, that of Japan is decreas-

masturbation or too strong a grip. Teaching adequate masturbationing, and the reduction in birthrate has become an urgent issue intechniques is essential in the treatment of such patients. To improve

Japan. The demand for infertility treatment is increasing as a part ofinadequate masturbation, training with a hand-­held cup-­t ype ejacu-

fertility reduction strategies, and the importance of infertility treat-lation device may be an ideal and realistic tool because the patientsment for both male and female infertility is growing. In Japan, large-­

were reported to be able to ejaculate vaginally after training withscale surveys on male infertility, including causes and treatment,

it.5 Indeed, the number of patients treated with this device for intra-

12

were conducted in 2007 and 2015. Spermatogenesis dysfunction

vaginal EjD has appeared to increase in Japan. However, no studies

accounts for more than 80% of male infertility, but sexual dysfunc-

have been reported that scientifically analyze the efficacy or safetytion is also a major cause. In 2007, sexual dysfunction accounted forof treatment with this kind of device. In addition, more advanced

only 3.3% of cases, but in 2015, it accounted for as much as 13.5%.

devices are now available that are not manually operated. The A10

Erectile dysfunction (ED) is considered the most common type of

Cyclone SA + PLUS® (Rends Co., Ltd.) (Figure 1) masturbation aid issexual dysfunction, but when looking at the causes of infertility,

a motorized, free-­standing device that allows the user to adjust theejaculation disorder (EjD) and ED accounted for 7.4% and 6.1% of theintensity of stimulation, movement, and lumen size. Thus, we spec-

total, respectively. This may mean that EjD has been becoming moreulated that training with this new device, which closely resembles

common than ED in young patients with sexual dysfunction who

the vaginal environment during sexual activity, could be a treatment

wish for a baby. For patients with ED, a phosphodiesterase type-­5

option for EjD, for which no definitive treatment currently exists.

(PDE5) inhibitor has been used as the first-­line treatment, and its

Thus, the purpose of this study was to evaluate the efficacy andhigh efficacy is well known. However, the treatment strategy for EjD

safety of the A10 Cyclone SA + PLUS ejaculation aid for patients withhas not been fully established. In general, EjD as a cause of infertility

intravaginal EjD.

mainly includes retrograde ejaculation and intravaginal EjD. From a
global perspective, intravaginal EjD has not received nearly as muchattention, and the treatment of premature ejaculation is the main-

2|

M ATE R I A L S A N D M E TH O DS

stay of EjD. Indeed, there have been several studies showing theeffectiveness of training for premature ejaculation.3 Furthermore,

After obtaining consent, each participant was instructed to perform

although there are also some effective drugs for retrograde EjD, suchpractice masturbation with an A10 Cyclone SA + PLUS to simulate

as tricyclic antidepressants,4 there are no approved drugs or devices

vaginal ejaculation. The machine is easily available through online

for the treatment of intravaginal EjD, and the treatment for this kindshopping sites and can be purchased for around 300 US dollars. Itof EjD is often difficult for urologists and general physicians.

is not disposable and requires a separate purchase of an attachment

In Japan, the concept of intravaginal EjDs has gained increasing
attention from the perspective of an aging society with declining

for the part to be inserted, but the attachment can be cleaned andused repeatedly.

birthrates. In particular, an increasing number of young male fertility

The frequency of masturbation, with the goal being one to threepatients, even though they have no erectile problems, feel strong

times per week, and the duration and position of each masturbationpressure from their spouses or close relatives to have a baby andpractice were at the discretion of each individual participant. Afterare unable to sustain an erection until ejaculation during sexual

8 weeks of training, attending physician asked the participants about

F I G U R E 1 The A10 Cyclone
SA + PLUS® ejaculation aid.

14470578, 2023, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12530 by Cochrane Japan, Wiley Online Library on [17/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

2 of 6their intravaginal ejaculation status and whether any adverse events<0.05 was considered statistically significant. We used IBM SPSS

had occurred. Patients were also evaluated by questionnaires to as-

Statistics for Windows, Japanese version 20 (IBM Japan) for the sta-sess ejaculatory function, including intravaginal ejaculation and erec-

tistical analysis.

tile function, before and after the training. For ejaculatory function,
we used the numerical rating scale6 (NRS) to assess ejaculatory satisfaction based on a rating system in which the best is 0 and the worst

3|

R E S U LT S

is 10, and the Male Sexual Health Questionnaire for assessing ejaculatory dysfunction7 (MSHQ-­EjD), which is a specific questionnaire for

Of the 15 entrants, 10 completed both the 8-­week training and theejaculation. This questionnaire contains four questions related to EjD

pre-­ and post-­training questionnaire assessments. Of these 10 par-that the participants need to answer. Three of the four questions relateticipants, four (40%) became capable of intravaginal ejaculation after

to assessing a participant's ejection function, including completion oftraining, and these four comprised the IVEjPG. Table 1 shows theejaculation, intensity of ejaculation, and volume of semen at the time ofoverall scores of the questionnaires. The Mean participant age was

ejaculation (MSHQ-­EjD ejaculatory function). All questions are scored41.5 ± 3.21 years, and the mean score of the IIEF-­5 was 13.5 ± 2.15,

from 0 to 5 depending on the ejection function rating, with lower scores

which indicated mild-­to-­moderate ED. Table 2 shows the age andindicating more severe ejection function. Thus, the minimum score is 0,score before the training between the IVEjPG and IVEjIG. Although

and the maximum score is 15. The fourth question on the MSHQ-­EjD is

the participants in the IVEjPG were relatively older (46.5 years) thanrelated to bother or satisfaction with ejaculatory function: “If you havethose in the IVEjIG (37.5 years), this difference did not reach sta-

had ejaculation difficulties or have been unable to ejaculate, have youtistical significance. The NRS score was significantly higher in the

been bothered by this?” Bother/satisfaction was rated from 0 (no prob-

IVEjPG than the IVEjIG. As higher NRS scores indicate lower ejacu-lem) to 5 (extremely bothered). Overall sexual function was assessedlation satisfaction, ejaculation satisfaction even before training wasusing the International Index of Erectile Function8 (IIEF), and ED waslower in the IVEjPG. Although other factors, including the score of

910especially assessed using the IIEF-­5 and the Erection Hardness Score

MSHQ-­EjD ejaculatory function and bother/satisfaction, IIEF, IIEF-­5,(EHS). We further assessed sexual confidence with the Confidence in

EHS, and CPSIQ12, were all lower in the IVEjPG than in the IVEjIG,

Performing Sexual Intercourse Questionnaire-­1211 (CPSIQ-­12), which

they did not differ significantly. When changes in scores due to train-

contains 12 questions on confidence in engaging in sexual activity. It is

ing were evaluated in each group (Table 3), only the NRS of IVEjPG

scored on a 7-­point scale from “very unsure” to “very confident,” espe-

was found to improve significantly. For MSHQ-­EjD ejaculatory func-

cially for hardness and maintenance of erection, with the more confi-

tion, although the scores of the IVEjPG tended to increase after thedent participants scoring higher. Of the 15 men entered into this study,

training (from 3.5 ± 1.54 to 9.0 ± 0.65), this change did not reach sta-

10 (aged 41.5 ± 3.21 years) completed both the 8-­week training andtistical significance (p = 0.08). No adverse events of bleeding, pain,

the pre-­ and post-­training questionnaire assessments. We compared

persistent erection, or other events were observed throughout thethe pre-­treatment condition of the group that became capable of in-training.

travaginal ejaculation (intravaginal ejaculation possible group; IVEjPG)
and the group that did not (intravaginal ejaculation impossible group;
IVEjIG) after the training and attempted to clarify the characteristics of

4|

DISCUSSION

the IVEjPG. We also evaluated the changes in the scores of the various
questionnaires in each group.

In this study using the A10 Cyclone SA + PLUS, 40% of the participants who completed the treatment were able to ejaculate vaginally.

2.1 | Ethical approval and informed consent

TA B L E 1 Overall questionnaire scores of the 10 patients withintravaginal ejaculatory dysfunction.

The study protocol complied with Good Clinical Practices and theAge, years

41.5 ± 3.21

Declaration of Helsinki (1996) and was performed in accordance with

NRS

4.5 ± 1.06

applicable institutional review board regulations. The protocol was

MSHQ-­EjD ejaculatory function

8.0 ± 1.49

approved by the institutional review board of Juntendo University

MSHQ-­EjD bother/satisfaction

Urayasu Hospital, Chiba, Japan (approval no. 2020-­3-­021). The

1.5 ± 0.66

IIEF

41.0 ± 3.22

IIEF-­5

13.5 ± 2.15

study participants gave informed consent before the initiation of any
study-­related procedures and medications.

2.2 | Statistical analysis
Data are presented as the mean ± standard error. Statistical significance was determined by a paired and unpaired t-­test. A p value

EHS

3.0 ± 0.51

CPSIQ-­12

2.0 ± 0.36

Abbreviations: CPSIQ-­12, Confidence in Performing Sexual Intercourse
Questionnaire-­12; EHS, Erection Hardness Score; IIEF, International
Index of Erectile Function; MSHQ-­EjD, Male Sexual Health
Questionnaire for assessing Ejaculatory Dysfunction; NRS, numericalrating scale.

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FUKUHARA et al.

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FUKUHARA et al.

In the absence of effective treatments for intravaginal EjD, the fact

disorders are classified into five types: early ejaculation, delayedthat as many as 40% of the participants could ejaculate vaginally is aejaculation, retrograde ejaculation, and two other specified ejac-

breakthrough, and it is expected that the treatment reported herein

ulatory dysfunctions. The 2022 American Urological Association/

will be applied for intravaginal EjD in the future.

Sexual Medicine Society of North America guideline,14 which is

There are several ways of classifying EjD around the world.

the most recent guideline, describes two forms: premature and

The 2015 4th International Consultation on Sexual Medicine

delayed ejaculation. The concept of intravaginal EjD does not exist

Classification12 classifies EjDs into the following 9 types: pre-in any of these classifications. While intravaginal EjD may be per-mature ejaculation, delayed ejaculation, retrograde ejaculation,

ceived as a disease unique to Japan, in fact, there must be similar

anejaculation, anhedonic ejaculation (nonenjoyable ejaculation),patients in other countries, but they may be placed in the “delayedanorgasmia, hypohedonic orgasm (low enjoyable orgasm), pain-

ejaculation” category. Various treatments for delayed ejaculation

ful ejaculation, and postorgasmic illness syndrome. According tohave been suggested to be effective.15 In drug therapy, cabergo-

the 2018 International Classification of Diseases,13 ejaculatory

line16 and bupropion17 are commonly used in the United States,

TA B L E 2 Baseline scores in the intravaginal ejaculation possiblegroup and intravaginal ejaculation impossible group.

albeit off label. Psychological approaches18 and penile vibratory
stimulation19 are also used. Although there are many reports ofefficacy, there is a lack of solid evidence, and more research isneeded. Even though the concept of intravaginal EjD itself may

IVEjPGIVEjIG

N=4

N=6

p

Age, years

46.5 ± 5.15

37.5 ± 4.08

0.81

NRS

9.5 ± 1.03

3.0 ± 1.04

0.02

MSHQ-­EjD
ejaculatory
function

3.5 ± 1.54

9.5 ± 1.79

0.1

MSHQ-­EjD bother/satisfaction

1.0 ± 1.02

2.5 ± 0.84

0.55

IIEF

33.5 ± 3.34

46.5 ± 4.25

0.19

IIEF-­5

12.5 ± 2.77

18.0 ± 2.95

0.51

EHS

2.5 ± 0.41

4.0 ± 0.45

0.17

CPSIQ121.0 ± 0.22

2.0 ± 0.51

0.17

not be global and there is no term for it in the Western literature, Japanese institutions have reported the presence of many
patients with intravaginal EjD. 20 As patients with intravaginal EjD
can achieve erections and ejaculate normally during masturbation, it is unlikely that their EjD is caused by physical dysfunction.
Rather, it is assumed that in most cases, psychogenic factors are

Abbreviations: CPSIQ-­12, Confidence in Performing Sexual Intercourse
Questionnaire-­12; EHS, Erection Hardness Score; IIEF, International
Index of Erectile Function; IVEjIG, intravaginal ejaculation impossiblegroup; IVEjPG, intravaginal ejaculation possible group; MSHQ-­
EjD, Male Sexual Health Questionnaire for assessing Ejaculatory
Dysfunction; NRS, numerical rating scale.

strongly involved, which is why EjD is more likely to occur duringhigh-­p ressure pregnancy activities such as timing therapy.
Because patients with intravaginal EjD can still insert their penis
into a vagina, they are not often seen when they are unmarried, butthey often visit a specialist when the goal is to become pregnant.
Otani20 reported that 40%–­58% of patients with EjD who visited amale infertility clinic at a high-­volume center in Japan had intravaginal EjD. The inability to ejaculate intravaginally is a problem whentrying to conceive. There are two main causes of intravaginal EjD: inappropriate stimulation during masturbation and psychogenic disorders. Psychogenic causes include those who cannot concentrate on
ejaculation unless they are alone, those who develop the condition

TA B L E 3 Change of questionnaire scores of the intravaginal ejaculation possible group and intravaginal ejaculation impossible group.
IVEjPGIVEjIG

N=4

N=6

BeforeAfterp

Before

After

p

NRS

9.5 ± 1.03

6.0 ± 1.09

0.02

3.0 ± 1.04

8.0 ± 1.26

0.08

MSHQ-­EjD ejaculatory
function

3.5 ± 1.54

9.0 ± 0.65

0.08

9.5 ± 1.79

9.0 ± 2.37

0.54

MSHQ-­EjD bother/satisfaction

1.0 ± 1.02

3.5 ± 0.41

0.3

2.5 ± 0.84

4.0 ± 0.91

0.84

IIEF

33.5 ± 3.34

42.0 ± 5.63

0.33

46.5 ± 4.25

52.5 ± 5.41

0.88

IIEF-­5

12.5 ± 2.77

19.0 ± 2.90

0.33

18.0 ± 2.95

23.0 ± 3.20

0.81

EHS

2.5 ± 0.41

2.5 ± 0.25

0.71

4.0 ± 0.45

3.0 ± 0.43

0.08

CPSIQ121.0 ± 0.22

2.0 ± 0.54

0.25

2.0 ± 0.51

2.5 ± 0.45

0.68

Abbreviations: CPSIQ-­12, Confidence in Performing Sexual Intercourse Questionnaire-­12; EHS, Erection Hardness Score; IIEF, International Index of
Erectile Function; IVEjIG, intravaginal ejaculation impossible group; IVEjPG, intravaginal ejaculation possible group; MSHQ-­EjD, Male Sexual Health
Questionnaire for assessing ejaculatory dysfunction; NRS, numerical rating scale.

14470578, 2023, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12530 by Cochrane Japan, Wiley Online Library on [17/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

4 of 6following instruction in the timing method, and those who have asuperiority over manual ejaculation aids already reported, as there

particular object of sexual stimulation. In our clinical practice, we

are no more comprehensive reports than those of past case reports.

often encounter patients with intravaginal EjD due to inappropriate
stimulation or masturbation methods. If the patient is masturbating
inadequately, he should be guided to masturbation using thrusting5|

CO N C LU S I O N

movements with a soft grip. However, in many patients, there areproblems with long-­term masturbation methods that have continued

Free-­standing motorized ejaculation aids have shown good results insince puberty, so guidance is difficult in many cases. There have been

the treatment of intravaginal EjDs, for which no effective treatmentcase reports in Japan using ejaculation aids as a training method, andexists. The present study participants experienced no significant

some effectiveness has been reported. If masturbation instruction isside effects from use of the A10 Cyclone SA + PLUS, and the ability

not successful, masturbation can be performed in the supine posi-

to ejaculate vaginally improved ejaculation satisfaction, indicatingtion, and when the patient is about to ejaculate, the penis is inserted

that a self-­supporting electric ejaculation aid may be a useful tool infor intravaginal ejaculation with the woman in the supine position.

the treatment of intravaginal EjD.

Although there are no guidelines for EjD in Japan, in the mostwell-­known classification by Otani, 20 EjD was classified into (1) both

AC K N OW L E D G M E N T S

masturbation and intravaginal EjD (retrograde ejaculation, inability

Rends Co., Ltd. provided the A10 Cyclone SA + PLUS® ejaculation

to ejaculate either forwardly or retrogradely), (2) intravaginal EjD,

aid.

(3) abnormal time to ejaculation (premature or delayed ejaculation),(4) lack of orgasm, and (5) headache or ejaculation pain during ejac-

C O N F L I C T O F I N T E R E S T S TAT E M E N T

ulation. As mentioned above, intravaginal EjD is a major problem in

The authors declare no conflict of interest.

Japan, so the use of intravaginal EjD as a classification method is
considered very useful in clinical practice, especially in the treatment

H U M A N R I G H T S S TAT E M E N T S A N D I N FO R M E D

of EjD in male infertility clinics. As intravaginal EjD appears to be a

CONSENT

concept unique to Japan, there is, to our knowledge, no literature in

All procedures followed were in accordance with the ethical stand-

Europe or the United States that examines intravaginal EjD. In theards of the responsible committee on human experimentation (in-era of assisted reproductive technology, it is possible to have a baby

stitutional and national) and with the Helsinki Declaration of 1964

with intrauterine (artificial) insemination, in vitro fertilization, andand its later amendments. Informed consent was obtained from all

intracytoplasmic sperm injection, even for patients with intravaginal

participants included in the study.

EjD. However, if intravaginal EjD can be overcome, a natural pregnancy will be possible. We believe that a natural pregnancy should

ORCID

be vastly preferable and will be of great benefit to couples who

Akira Tsujimura

https://orcid.org/0000-0002-3821-5184

wish to have a child. In the present study, ejaculation satisfaction
increased significantly in the IVEjPG. This suggests that intravaginal

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How to cite this article: Fukuhara S, Shirai M, Ueda N,
Takezawa K, Ishikawa K, Hiramatsu I, et al. Therapeutic
efficacy and safety of a free-­standing motorized ejaculation
aid for patients with intravaginal ejaculatory dysfunction.
Reprod Med Biol. 2023;22:e12530. https://doi.org/10.1002/
rmb2.12530

14470578, 2023, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/rmb2.12530 by Cochrane Japan, Wiley Online Library on [17/08/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

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